At our organization, we are dedicated to advancing healthcare and life sciences by offering innovative product and service solutions worldwide. We are currently seeking a Quality Supervisor to play a key role in managing processes and leading projects to uphold and enhance our quality standards in accordance with various regulatory requirements, including ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other applicable standards.
The Quality Supervisor will lead a team comprising Technicians, Senior Technicians, and Analysts/Engineers. This role takes charge of complaint/non-conformance/CAPA investigations, supplier quality enhancements, continuous improvement initiatives, and countermeasures. Utilizing statistical techniques and recognized quality principles, the Quality Supervisor will make recommendations, plan, and execute activities related to the development, implementation, maintenance, and continuous improvement of our quality systems.
- Coordinate day-to-day tasks and provide technical support, mentoring, and oversight to Quality Technicians/Senior Quality Technicians and Quality Analysts/Engineers.
- Oversee product and report pre-reviews and releases conducted by the aforementioned personnel.
- Execute product and/or report releases for processing runs/lab samples containing non-conformance, including managing Customer communication and leading non-conformance investigations as necessary.
- Review and recommend approval for sterilization process validation protocols and final reports generated through the EO and/or Gamma Tech Center.
- Review and enhance the current quality system, developing analyses and reports on its performance.
- Utilize data to perform statistical analysis and suggest process improvements to enhance service quality.
- Lead the sites bowler/countermeasure process for annual quality objectives.
- Lead projects focused on quality system and service quality improvements.
- Lead and support internal and external quality system audits, including regulatory authorities, notified bodies, Customers, and perform supplier audits and internal audits at other facilities. Responsible for managing the follow-up process for audit observations.
- Lead process and product corrective actions and problem-solving activities.
- Instruct and guide other team members in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and facilities within the organization on quality-related issues.
- Travel to other facilities, both domestically and globally, to support remediation activities, audits/inspections, and continuous improvement initiatives.
- Overall responsibilities include a commitment to ensure external and internal requirements are met according to documented policies, procedures, standards, and regulations.
- Perform all other duties as assigned.
- Bachelor's Degree
- 6-8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 6-8 years of experience with medical device or other regulated industries preferred.
- 6-8 years of experience working in an ISO certified environment required.
- 2-3 years of supervisory/project leadership/oversight required.
- Sterilization experience preferred.
- Working knowledge of FDA QSR/EUGMP regulations strongly preferred.
For further information on this role in Offaly please contact Katie Kilbane on +353 86 1283368 or email email@example.com Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
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